STEMCELL Technologies Inc. is a privately-owned biotechnology company based in Vancouver that helps power leading-edge life science research around the world. Scientists performing stem cell, immunology, cancer, regenerative medicine and cellular therapy research are among those who rely on our cell culture media, cell separation products, instruments, ancillary reagents and contract assay services. We create novel, useful, standardized products of unfailing quality and deliver them to more than 70 countries via our many regional offices plus distribution centres in Vancouver, Seattle, Grenoble and Singapore. Driven by our love of science and our passion for quality, we see ourselves simply as “Scientists Helping Scientists” – standing by our customers to provide outstanding products, technical support and training. We have over 950 science-oriented employees globally, including 250 PhDs/MScs, with most others holding a BSc or engineering degree. STEMCELL is proud to be the largest Biotechnology employer in Canada.
Job Description Summary
The Senior Manager, Process Engineering will lead the Process Engineering team within the Process Development department. The primary focus of this position is to contribute to the strategic planning and execution of manufacturing process improvements, capital projects and to provide engineering support to other departmental projects as needed.
DUTIES AND RESPONSIBILITIES
- Take a lead role in the new manufacturing site project from design, through construction, commissioning, validation and start-up
- Lead the design, specification, procurement, commissioning and qualification of process equipment in collaboration with other stakeholder departments
- Oversee the engineering aspects associated with technology transfer from Research and Development to Manufacturing and Contract Manufacturing Organizations (CMOs)
- Apply state of the art engineering concepts to the establishment of standardized manufacturing processes
- Oversee the planning and execution of process trials in laboratories and pilot plants to optimize the manufacturing process
- Oversee the Implementation of process controls and development of test methods to assess the production process
- Identify potential cost efficiencies by investigating alternative materials and equipment to improve efficiency, quality and yields in bottleneck areas
- Oversee the training and engineering support to manufacturing team
- Support daily production and assist in troubleshooting processes and equipment as needed
- Write technical reports, equipment design specifications and protocols compliant with STEMCELL’s quality management system
- Utilize industry practices such as LEAN, Six Sigma and Project Management methodologies
- BSc or MSc Engineering degree with 10 to 15 years of industrial experience
- Experience with current good manufacturing practices (cGMPs) in a regulated industry complying with 21 CFR part 210, 211 or 820
- Excellent understanding of equipment qualification, process validation, aseptic technologies and/or bioreagent manufacture.
- Extensive knowledge of scale-up of unit operations such as: mixing, filtration and filling; heat and mass transfer; process improvements and optimization.
- Experience with management and supervision of process engineering staff
- Must be highly motivated, have excellent interpersonal and leadership skills, be highly independent, and have effective organizational, verbal and written communication skills
This is an opportunity to work with highly motivated colleagues in a science-oriented, creative and dynamic environment. We offer a competitive salary, excellent benefits and significant career development opportunities. If you are interested in this challenging and rewarding position, please apply here